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Completed

NCT Number: NCT00622284

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably > 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1218.20.35201 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
  • Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
  • HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
  • HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

Exclusion criteria

  • Myocardial infarction, stroke or transient ischemic attack (TIA)
  • Impaired hepatic function
  • Renal failure or renal impairment
  • Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
  • Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening

Treatment and study plan

Placebo identical to BI 1356 5mg

Drug

Placebo tablet once daily

Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg

Drug

Placebo tablets once daily

BI 1356

Drug

5mg, once daily in the morning for 104 weeks

Glimepiride

Drug

1mg or 2mg or 3mg or 4mg in the morning for 104 weeks

Primary outcomes

  1. HbA1c Change From Baseline at Week 52

    Time frame: Baseline and week 52

    This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.

  2. HbA1c Change From Baseline at Week 104

    Time frame: Baseline and week 104

    This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.

Secondary outcomes

  1. Body Weight Change From Baseline at Week 52

    Time frame: Baseline and week 52

    This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.

  2. Body Weight Change From Baseline at Week 104

    Time frame: Baseline and week 104

    This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.

  3. Incidence of Hypoglycaemic Events up to 52 Weeks

    Time frame: Week 52

    A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)

  4. Incidence of Hypoglycaemic Events up to 104 Weeks

    Time frame: Week 104

    A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)

  5. Fasting Plasma Glucose (FPG) Change From Baseline at Week 52

    Time frame: Baseline and week 52

    This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.

  6. Fasting Plasma Glucose (FPG) Change From Baseline at Week 104

    Time frame: Baseline and week 104

    This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.

  7. Percentage of Patients With HbA1c <7.0% at Week 52

    Time frame: Week 52

    The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

  8. Percentage of Patients With HbA1c <7.0% at Week 104

    Time frame: Week 104

    The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

  9. Percentage of Patients With HbA1c <6.5% at Week 52

    Time frame: Week 52

    The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

  10. Percentage of Patients With HbA1c <6.5% at Week 104

    Time frame: Week 104

    The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

  11. Percentage of Patients With HbA1c Lowering by 0.5% at Week 104

    Time frame: Week 104

    Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104

  12. 2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104

    Time frame: Baseline and week 104

    This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications.

  13. HbA1c Change at Week 4

    Time frame: Baseline and week 4

    Difference of base percent value [Week x(%) - baseline (%)]

  14. HbA1c Change at Week 8

    Time frame: Baseline and week 8

  15. HbA1c Change at Week 12

    Time frame: Baseline and week 12

  16. HbA1c Change at Week 16

    Time frame: Baseline and week 16

  17. HbA1c Change at Week 28

    Time frame: Baseline and week 28

  18. HbA1c Change at Week 40

    Time frame: Baseline and week 40

  19. HbA1c Change at Week 52

    Time frame: Baseline and week 52

  20. HbA1c Change at Week 65

    Time frame: Baseline and week 65

  21. HbA1c Change at Week 78

    Time frame: Baseline and week 78

  22. HbA1c Change at Week 91

    Time frame: Baseline and week 91

  23. HbA1c Change at Week 104

    Time frame: Baseline and week 104

    The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule.

  24. Change in Baseline Lipid Parameter Cholesterol at Week 104

    Time frame: Baseline and week 104

  25. Change in Baseline Lipid Parameter HDL at Week 104

    Time frame: Baseline and week 104

  26. Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104

    Time frame: Baseline and week 104

  27. Change in Baseline Lipid Parameter Triglyceride at Week 104

    Time frame: Baseline and week 104

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

Important dates

Study start
2008
Primary completion
2010
First posted
Feb 25, 2008
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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